FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
NATURATLALI S DE RL DE CV
Effective date
2020-11-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:09

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame.

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on open wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water USP, glycerin, carbomer, triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200000 mL NDC: 77143-005-01

200000 mL200000 mL

3785 mL NDC: 77143-005-02

3785 mL3785 mL

1000 mL NDC: 77143-005-03

1000 mL1000 mL

500 mL NDC: 77143-005-04

500 mL500 mL

19000 mL NDC: 77143-005-05

19000 mL19000 mL

118 mL NDC: 77143-005-06

118 mL118 mL

250 mL NDC: 77143-005-07

250 mL250 mL

350 mL NDC: 77143-005-09

350 mL350 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN4
1041498ethanol 0.8 ML/ML Topical GelSCD4
1041498ethanol 80 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77143-005-012023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-022023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-032023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-042023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-052023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-062023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-072023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol
77143-005-092023-01-30C16284748780-1f386c649-a5de-0266-e053-dadaa90a7c1aProteX NDC: 77143-005 Antibacterial 80% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77143-005-01Hand Sanitizer200000 mL in 1 DRUMGEL2000004
77143-005-02Hand Sanitizer3785 mL in 1 CONTAINERGEL37854
77143-005-03Hand Sanitizer1000 mL in 1 BOTTLEGEL10004
77143-005-04Hand Sanitizer500 mL in 1 BOTTLEGEL5004
77143-005-05Hand Sanitizer19000 mL in 1 CONTAINERGEL190004
77143-005-06Hand Sanitizer118 mL in 1 BOTTLEGEL1184
77143-005-07Hand Sanitizer250 mL in 1 BOTTLEGEL2504
77143-005-09Hand Sanitizer350 mL in 1 BOTTLEGEL3504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77143-005HAND SANITIZER (ALCOHOL) GEL [NATURATLALI S DE RL DE CV]4Legacy NDC, 8 package rows20201124_a7abbdfe-3001-6a20-e053-2995a90ab952.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77143-00577143-005-05, 77143-005-04, 77143-005-03, 77143-005-02, 77143-005-01, 77143-005-06, 77143-005-07, 77143-005-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
EDETIC ACID9G34HU7RV0IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b4cad147-9c35-0e47-e053-2a95a90a95d4a7abbdfe-3001-6a20-e053-2995a90ab9522020-11-23WarningsExact identifier
spl id: b4cad147-9c35-0e47-e053-2a95a90a95d4
spl set id: a7abbdfe-3001-6a20-e053-2995a90ab952

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.